NMPA Approves Ciprocopan for PNH in China
NMPA approves ciprocopan PNH China for adults who have not previously received a complement inhibitor. Haisco said on July 23, 2026 that ciprocopan succinate tablets (HSK39297) won Class 1 innovative-drug marketing authorization as a once-daily oral Factor B inhibitor for paroxysmal nocturnal hemoglobinuria.
Contents10 sections
Key Takeaways
- NMPA approved Haisco's ciprocopan succinate tablets for complement-inhibitor-naive adult PNH on July 23, 2026.
- Haisco positioned the product as the first once-daily oral complement Factor B inhibitor globally.
- No food effect and no dose adjustment for mild/moderate renal impairment or mild-to-severe hepatic impairment were claimed in the company release.
- Nuvectis said a China filing for anti-C5–experienced PNH patients is still under review.
Ciprocopan at a glance
| Field | Detail |
|---|---|
| Drug | Ciprocopan succinate tablets (HSK39297 / NXP100) |
| Sponsor (China) | Haisco Pharmaceutical Group |
| Partner disclosure | Nuvectis Pharma (NXP100) |
| Regulator | China NMPA |
| Action | Marketing approval announced July 23, 2026 |
| Population | Adults with PNH previously untreated with complement inhibitors |
| Class | Oral complement Factor B (FB) inhibitor, once daily |
What did the NMPA approve?
Haisco said China's National Medical Products Administration approved ciprocopan succinate tablets for adult patients with PNH who are complement-inhibitor-naive. The company called this its fifth innovative drug approved for marketing and framed the product as addressing residual anemia and breakthrough-hemolysis risks seen with some C5-pathway regimens.
Details are in Haisco's July 23 PR Newswire approval release.
How does Factor B inhibition fit PNH care?
PNH is a rare acquired clonal hematopoietic stem-cell disorder marked by intravascular hemolysis, marrow failure, and thrombosis. Haisco cited China's 2024 PNH guideline recommending complement inhibitors as first-line therapy for classic PNH, while noting C5 inhibitors control intravascular hemolysis but do not block upstream alternative-pathway initiation.
Ciprocopan targets Factor B to inhibit alternative-pathway initiation and amplification. Convenience claims in the release include once-daily oral dosing without regard to food.
What did partner disclosures add?
Nuvectis Pharma separately reported the China marketing approval for ciprocopan (NXP100) in complement-inhibitor-naive PNH and described it as the first global approval of a once-daily oral Factor B inhibitor. The company said approval rested on Haisco's completed China clinical development program and that a China application for patients previously treated with anti-C5 therapies remains under review.
See Nuvectis' July 23 GlobeNewswire China approval notice.
What else is in Haisco's innovation stack?
- Four prior Class 1 drugs—cipepofol, anrikefon, cofrogliptin, and crisugabalin—are on China's NRDL, per Haisco
- Cipepofol gained U.S. FDA approval in late May 2026 as a China-originated IV anesthetic, Haisco said
- The group cited more than RMB 1 billion annual R&D spend and 27 Class 1 programs in pipeline
Broader China pathway context is covered in our note on NMPA China drug-approval pathways.
What remains uncertain?
The approval wires do not republish full Phase 3 hemoglobin, LDH, or transfusion-avoidance tables. Labeled dosing, monitoring for meningococcal infection risk typical of complement blockade, and NRDL timing for ciprocopan were not disclosed. Anti-C5–experienced use in China is not yet approved.
Related NovaPharma coverage
- NMPA Drug Approvals Surge in 2025
- Cell and Gene Therapy Approvals in China
- Hansoh HS-10541 NMPA trial nod for KRAS G12C
Frequently Asked Questions
What did China's NMPA approve for ciprocopan?
On July 23, 2026, Haisco said the NMPA approved ciprocopan succinate tablets (HSK39297) for adult patients with paroxysmal nocturnal hemoglobinuria who are complement-inhibitor-naive. The company described it as the world's first once-daily oral complement Factor B inhibitor.
Who developed ciprocopan for the China approval?
Haisco Pharmaceutical Group said it independently developed the Class 1 innovative drug with full IP. Nuvectis Pharma separately announced the China marketing approval and noted a second China application for patients previously treated with anti-C5 therapies remains under review.
How is ciprocopan dosed according to Haisco?
Haisco said ciprocopan is taken once daily, may be taken without regard to food, and requires no dose adjustment for mild or moderate renal impairment, for mild-to-severe hepatic impairment, or when coadministered with strong CYP2C8 inhibitors.
Primary Sources
Regulatory catalyst tracker
Track PDUFA dates, approval milestones, and label updates for ciprocopan.
Unlock full calendar →Entity graph
Continue Exploring
Open the drugs, companies, and topics behind this story.
This article follows our editorial standards. Report a correction via editorial contact.
Deeper reading
Industry reports & whitepapers
- FDA CBER Patient Listening Meeting on Gene Therapy Safety: Patient and Care Partner Perspectives — Patient and care partner perspectives inform FDA’s thinking on approved gene therapy safety and long…